Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences

NCT ID: NCT00540371

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2009-02-28

Brief Summary

The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment.

The objective of this study is to document the degree of port wine stain lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved treatment.

Detailed Description

The flashlamp-pumped pulsed dye laser has offered the best results with the lowest incidence of side effects. The yellow light is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis.

The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due to partial absorption of energy therein by melanin which presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during pulsed laser treatment of port wine stain birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment purpura.

Conditions

Port Wine Stain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Port wine stain Birthmark

Port wine stain Birthmark

Port wine stain Birthmark

Intervention Type: OTHER

Port wine stain Birthmark

Interventions

Port wine stain Birthmark

Port wine stain Birthmark

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
• Apparent good health as documented by medical history and physical examination
• Ability to understand and carry out subject instructions

Exclusion Criteria

• Pregnancy
• History of cutaneous photosensitivity
• History of photodermatoses, skin cancer or other cancer
• Any therapy to the proposed treatment sites within the previous two months
• Current participation in any other investigational drug evaluation
• Concurrent use of known photosensitizing drugs
• Inability to understand and carry out subject instructions

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Kristen Kelly, M.D.,Professor Departments of Dermatology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Kelly, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institue University of California Irvine

Locations

Beckman Lase Institute Medical Clinic Unversity of California Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

19992154

Identifier Type: -

Identifier Source: org_study_id